Kairos Pharma Reports Positive Safety Results from Phase 2 Trial of ENV-105 in Advanced Prostate Cancer
DENVER, Colo., Jul 15, 2025 (247marketnews.com)- Kairos Pharma (NYSE:KAPA) today announced encouraging safety results from the ongoing Phase 2 clinical trial evaluating ENV-105 (carotuximab) in patients with metastatic castration-resistant prostate cancer (mCRPC).
An interim safety analysis of the first ten patients enrolled in the study showed that ENV-105, a first-in-class CD105 antagonist, was well tolerated when combined with standard-of-care apalutamide (a hormone therapy). Importantly, there were no dose-limiting toxicities or unexpected adverse events reported, and no Grade 3 or 4 toxicities observed to date. Treatment-related side effects were described as manageable with standard supportive care.
John Yu, MD, Kairos Pharma’s CEO, stated, “The favorable safety profile observed in this Phase 2 study is encouraging, as it validates our belief in ENV-105’s clinical potential and supports continued development in a patient population with limited effective treatment options.”
Prostate cancer affects more than one million men annually in the U.S. alone, with resistance to hormone-based therapies posing a significant clinical challenge—especially in older populations. Castration-resistant prostate cancer describes tumors that continue to grow despite hormonal suppression, leaving few effective treatment options.
The current randomized Phase 2 trial is expected to enroll 100 patients and is actively recruiting at leading U.S. centers including Cedars-Sinai Medical Center, City of Hope, and Huntsman Cancer Center. The study is designed to assess the safety, tolerability, and preliminary efficacy of ENV-105 in men whose disease has progressed following hormone therapy.
Interim efficacy data are anticipated in September 2025, with Kairos Pharma planning to engage with regulatory authorities to discuss the design of a potential pivotal Phase 3 trial based on emerging results.
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